Trial Status: In Set-Up
Prospective randomised controlled trial comparing endoscopic decompression of the ulnar nerve at the cubital tunnel with open surgery.
Cubital tunnel syndrome is when a nerve is squashed at the elbow causing tingling and numbness in the hand, clumsiness of fine finger movements and loss of grip strength. Persisting symptoms can be treated with decompression surgery to release tight structures lying over the nerve.
There are two ways of performing decompression, one with open surgery where a cut is made in the skin along the course of the nerve, the other by keyhole surgery (endoscopic), with a small cut and using a camera to help see the nerve.
There are potential advantages and disadvantages of both techniques. After release, if the nerve moves excessively as the elbow bends the surgeon may need to correct the movement. This is easier with an open technique, but the extra scar from open surgery may cause symptoms to return. The keyhole surgery uses a smaller incision which may allow patients to recovery more quickly but is not currently performed regularly by UK surgeons.
The study will involve two phases. During the first phase surgeons will be trained to do the endoscopic surgery and information will be collected to help understand how quickly they learn the new skill and how well patients recover from surgery. The second phase involves conducting a study to compare the open and endoscopic operations using a randomised controlled trial. Patients agreeing to the study will be assigned at random to one of the two techniques (open or endoscopic). Information about their condition and recovery will be collected before and after surgery for a period of 6 months; 334 patients will be included from hospitals across the UK.